Kornimate/medical-research-clean huggingface dataset:
efficacy assessment of the cell therapy medicine nc1 in patients with post-traumatic syringomyelia

Conditions: Post-Traumatic Syringomyelia

Summary: the objective of the study is to determine if the cell therapy nc1 administered in the spinal cord is effective for the treatment of a post-traumatic syringomyelia. the post-traumatic syringomyelia is the development and progression of cyst filled with cerebrospinal fluid (csf) within the spinal cord. the cell therapy nc1 consist on cells obtained from the bone marrow of the patient, that are cultured in vitro and administered in the spinal cord of the same patient.

phase ii, open, prospective, not controlled, not randomized clinical trial in patients affected by post-traumatic syringomyelia. the trial evaluates the efficacy of the cell therapy nc1 administered via intrathecal in the location of the injury. after the administration of the cell therapy, patients will undergo physiotherapy during the follow-up period (6 months). patients will be evaluated at month 3 and month 6 after the nc1 administration.

Eligibility criteria:
inclusion criteria: * patients with traumatic medullar injury (levels a, b, c or d of the asia scale) and associated syringomyelia in at least three spinal segments, and with neurological deficit clinically stable at least 6 months prior to treatment. * previous studies in neurophysiology, mr, urology (if data on neurogenic bowel exists), defecatory function (if data on neurogenic intestine exists) * age between 18 and 70 years old. * presence of syringomyelia based on a neuro-image (mr) * patients will compromise to use anticonceptive measures from the cell extraction until 6 months after the administration of the treatment. * patients will compromise to a clinical follow-up and to perform physical therapy, one hour daily five days per week during the treatment period. * patients should sign an written informed consent. * haematological and creatinin parameters, sgot and sgpt into the normal ranges. exclusion criteria: * patients under 18 or above 70 years old * pregnancy or breastfeeding * neoplasia in the last 5 years * patients with systemic diseases that increase the risk of the surgical intervention * genetics alterations that could conduct to cellular transformation during the cellular expansion phase. * patients not really sure of their cooperation to follow the physical therapy or clinical controls during the study. * additional neurodegenerative diseases * drug consuming, psychiatric disease or allergy to proteins used during cellular expansion * hiv or syphilis positive serologies * active hepatitis b or c, based on serologies * any other reasons according to the investigator criteria.
a study of sa-001 to treat pancreatic exocrine insufficiency

Conditions: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Summary: this study is to verify the efficacy of 3.0 g/day of sa-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.


Eligibility criteria:
inclusion criteria * subjects with chronic pancreatitis in the non-compensatory stage or pancreatectomy * subjects whose cfa is 80% or less * subjects who are able to be hospitalized exclusion criteria * subjects who are judged to be difficult to have at least 40 g/day of fat intake during course of the study * subjects who have a known allergy to porcine protein and/or any component of digestive enzyme preparations * subjects who are in the acute phase of chronic pancreatitis * subjects with non-pancreatic malabsorption syndrome * subjects with acute pancreatitis or ileus

Keywords: sa-001 pancreatic exocrine insufficiency pancreatectomy
diuretic efficacy of aminophylline and furosemide combination vs furosemide alone in critically ill adults

Conditions: Acute Kidney Injury

Summary: the goal of this rct is to compare the effectiveness of aminophylline and furosemide combination vs furosemide alone in producing effective diuresis in critically ill adults in icu. icu patients with the need of improved diuresis will be recruited and given either infusion of aminophylline and furosemide combination or furosemide alone, and their hourly urine output will be monitored to compare their effectiveness.


Eligibility criteria:
inclusion criteria: * patients aged 18 years old and above who are admitted to the icu of ummc during the study period * oliguric patients, with the need for improved diuresis at clinician discretion - defined as urine output \<0.5ml/kg/hour exclusion criteria: * patient refusal for participation of study * patients with known hypersensitivity reaction to aminophylline or furosemide * patients with history of tachyarrhythmias, seizures, aspartate aminotransferase or alanine aminotransferase \> 3 times normal, or hypothyroidism. patient with existing peptic ulcer disease or coagulopathy with inr \> 1.5

Keywords: aminophylline furosemide critically ill adults intensive care unit (icu)
transcranial ultrasound in clinical sonothrombolysis

Conditions: Acute Ischemic Stroke

Summary: this is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of mrx-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tpa) treatment in subjects with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke * occlusion demonstrated by transcranial doppler ultrasound * eligible for tpa exclusion criteria: * right to left cardiac shunt * moderate to severe copd * uncontrolled hypertension

Keywords: acute ischemic stroke microbubbles transcranial doppler ultrasound tibi symptomatic intracranial hemorrhage modified rankin scale recanalization perflutren
physiotherapy for patients awaiting rotator cuff repair

Conditions: Rotator Cuff Tears

Summary: power is a pragmatic multi-centre, external pilot randomised controlled trial with feasibility objectives using a parallel group design with 1:1 allocation ratio and integrated qualitative study. the study aims to answer the question: in adult patients diagnosed with tears of the rotator cuff and awaiting elective surgical repair, is it feasible to conduct a future, fully powered, multi-site rct to test the hypothesis that physiotherapist-led exercise is superior to waiting-list control in terms of clinical and cost-effectiveness?

tears of the shoulder rotator cuff tendons are a common cause of shoulder pain, disability, and absence from work. once a decision to undergo rotator cuff repair surgery has been made, patients are placed on a waiting list, and it can take weeks or months to receive the surgery. while waiting for surgery, many patients continue to experience significant pain and disability, and some will be unable to work. if treatment could be delivered to patients while on the waiting list with potential to reduce pain and disability, and also potentially reduce the need for surgery, there would be clear and significant patient benefit and also benefit to the nhs. in this pilot study, the investigators will aim to find if it is possible to carry out a larger study to determine if a programme of physiotherapist-led exercise for patients awaiting surgery to repair torn shoulder rotator cuff tendons is clinically and cost-effective. working with 4 nhs hospitals, the investigators will recruit 76 patients waiting for rotator cuff repair surgery. one group of patients will receive a programme of specific exercise, supported by a physiotherapist. the second group will just continue waiting for surgery without additional treatment, which is current standard care. the programme of specific exercise can be supported over the telephone, via secure video platform, or face-to-face. the investigators will monitor patients through the study by asking participants to complete one questionnaire at the start and then three more electronic questionnaires after 6 weeks, 3 months and 6 months. the investigators will invite approximately 25 patients to take part in an interview to discuss experience of the treatments and the study. the study is being funded by the uk national institute for health research.

Eligibility criteria:
inclusion criteria: * adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff. exclusion criteria: * unable to provide informed consent.
efficacy of prophylactic treatment of oral prochlorperazine for acute mountain sickness

Conditions: AMS; Acute Mountain Sickness

Summary: a field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of ams, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, gi symptoms, fatigue and dizziness based on data collected in the lake louise ams score.

this was a prospective, single-blinded, field-based interventional trial involving consenting, healthy subjects aged \>17 years. the study was conducted on the big island of hawaii, at sea level and at the summit of mauna kea volcano. following randomization, subjects received either placebo or 10mg prochlorperazine, then immediately drove for 2 hours from sea level to the volcano summit (4205m). participants spent 240 min at the summit, and they recorded their symptoms. ams was defined by the previously validated lake louise acute mountain sickness score (llams). categorical variables were analyzed by chi-square; continuous variables analyzed by t-tests.

Eligibility criteria:
inclusion criteria - healthy subjects aged \>17 years exclusion criteria-subject meets any of the following: * known allergy or contraindication to the study drug. * known or suspected pregnancy. * use of another analgesic or antiemetic within 8 hours of enrollment. * history of chronic headaches. * inability to provide informed consent. * use of central nervous system depressants, including alcohol, opiates, and/or barbiturates, within 24 hours of the study start time. * history of severe depression. * history of dementia. * prior ascent and stay at 2500m for duration over 6 weeks within 30 days prior.

Keywords: prochlorperazine ams llams score acute mountain sickness
identification of novel targetable kinases in sr-a gvhd

Conditions: Graft Versus Host Disease

Summary: in this study, the investigators aim to identify novel targetable kinases in sr-a gvhd patient samples and investigate their role in different immune cell subtypes.

corticosteroids are the first-line treatment of a gvhd, however many patients do not respond to corticosteroids. patients with steroid-refractory a gvhd (sr-a gvhd) have a low 1-year survival rate. in this study, the investigators aim to identify and validate novel targetable kinases in sr-a gvhd patient peripheral blood mononuclear cells (pbmcs) by using a kinase-specific proteomic approach, and thereafter to investigate the role of the identified kinases in different immune cell subtypes by analyzing biopsies taken from sr- a gvhd patients.

Eligibility criteria:
inclusion criteria: * allo-transplanted * confirmed diagnosis of a gvhd * age ≥ 18 years * peripheral blood samples and biopsies available * written informed consent * ability to understand the nature of the study and the study-related procedures and to comply with them exclusion criteria: * age \< 18 years * lack of informed consent * patients that cannot be classified in one of the 2 groups (steroid-refractory, steroid-responsive)

Keywords: steroid-refractory gvhd myeloid cells allogeneic hematopoietic cell transplantation (allo-hct)
corneal endothelium in diabetics undergoing phacoemulsification

Conditions: Corneal Endothelial Cell Loss

Summary: evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.

diabetes mellitus (dm) is a major health hazard reaching epidemic proportions. worldwide more than 285 million people are affected by dm; this number is expected to increase to 439 million by 2030 according to the international diabetes federation. dm affects every part of the body and the eye is not an exception. diabetes mellitus has been found to be detrimental to corneal endothelium . patients with diabetes have been found to have morphologically abnormal endothelium, including pleomorphism and polymegethism. also, elderly patients with diabetes mellitus undergo phacoemulsification is particularly vulnerable to greater endothelial damage during surgery than non diabetics. several studies showed that diabetes mellitus has a lower impact on corneal cell density and morphology in patients with good glycemic control , also patients with diabetes over 10 years have more corneal morphological abnormalities than those having diabetes under 10 years duration. patients with dm tend to develop cataract more frequently and earlier than non diabetics. corneal endothelium plays an important role in maintaining dehydrated state and transparency of cornea throughout life, by pumping excess fluid out of stroma through active transport mechanism and barrier function. any compromise in these factors leads to direct effect on corneal endothelium . cataract has been documented to be the most significant cause of bilateral blindness . cataract extraction with phacoemulsification is one of the most common surgical procedure performed nowadays, with an estimated 19 million operation performed annually worldwide. the who states that this number will increase to 32 million by 2025, however corneal endothelium is known to undergo damage during phacoemulsification in many different ways, it may be injured mechanically as result of instrumentation causing postoperative complication such as corneal edema. specular microscopy is used for non invasive viewing and recording of the image of corneal endothelial cell layer. several studies have used specular microscopy for quantitative assessment of the corneal damage associated with phacoemulsification by measuring the degree of decrease in the corneal cell density.

Eligibility criteria:
inclusion criteria: * age from 40 to 70 * any degree of cataract * no previous ocular surgery exclusion criteria: * any corneal pathology, infection, or active inflammation * pseudoexofoliation * history of ocular trauma or surgery
fecal microbiota transplantation (fmt) in the management of active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: manipulation of the intestinal microbiota through fmt is a potential therapeutic target for ibd patients. studies are now required to determine if repeated fmt can overcome the apparent immune response to fmt thereby maintaining sustained clinical improvement and remission. prior to a large randomized controlled trial of fmt in uc we will carry out a feasibility study to determine if serial fmts can sustain a clinical response and maintain stability of transplanted microbiota.

same as above

Eligibility criteria:
inclusion criteria: 1. age \> 18 and \< 65 years 2. diagnosis of uc for \> 3 months but \< 5 years prior to screening as determined by the investigators 3. those with mild to moderate uc 4. those who have failed maintenance therapy with stable doses of 5-asa, azathioprine or 6 mercaptopurine (6-mp) for \> 3 months 5. where applicable, those who are taking the following medications must be at a stable dose defined as: i) 5-asa must be at a stable dose for 2 weeks ii) prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) azathioprine or 6-mp must be at a stable dose for \> 8 weeks 6. ability to provide informed consent 7. evidence of active inflammation exclusion criteria: 1. those whose disease is limited to the rectum (ie. proctitis) 2. those with colectomy or diverting ileostomy 3. those who are pregnancy or plan to be pregnant during the trial 4. those who are breastfeeding or plan to breast feed during the trial 5. those who are on or have previously failed a biological agent 6. those with an active infection requiring antibiotic therapy 7. those with positive stool cultures for known pathogens such as e coli, salmonella, shigella, yersinia, campylobacter, and clostridium difficile toxin within 2 weeks of enrollment 8. those with positive cmv on colonic tissue biopsy within 2 weeks of screening 9. those with allergy to ciprofloxacin and metronidazole 10. those with colonic mucosal dysplasia
low-dose leptin and the formerly-obese

Conditions: Obesity

Summary: our previous studies have demonstrated that there is substantial metabolic opposition to the maintenance of an altered body weight. leptin is a protein secreted by fat cells and the circulating concentrations of leptin are directly proportional to fat mass. leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. these studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. the basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or t3 supplementation.

we demonstrated a substantial metabolic resistance to maintenance of altered body weight. leptin is secreted by fat cells in circulating concentrations that are directly proportional to fat mass. leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. these studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. the basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or t3 supplementation.

Eligibility criteria:
healthy

Keywords: leptin obesity
phase ii study of the safety and efficacy of the relay thoracic stent-graft

Conditions: Thoracic Aortic Aneurysms; and Penetrating Atherosclerotic Ulcers

Summary: the purpose of this study is to evaluate the safety and efficacy of the relay thoracic stent-graft system to treat thoracic aortic aneurysms. efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via relay thoracic stent-graft) through 1-year. safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the relay thoracic stent-graft to those who underwent surgical repair. long term follow-up is conducted through 5 years.


Eligibility criteria:
inclusion criteria: * subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers * subjects who are at least 18 years of age * subjects whose anatomy can accommodate the relay device * subjects who consent to participate * subjects who agree to comply with follow-up schedule exclusion criteria: * subjects with non-aneurysm lesions * subjects with less than 1 year life expectancy * subjects who are pregnant * subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., marfan's syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.) * subjects participating in another investigational study
absorption, stable isotope appearance and non-transferrin-bound iron (ntbi) profile from nafeedta and ferrous sulphate

Conditions: Iron Deficiency

Summary: several iron compounds are used for fortification, including ferrous sulphate and nafeedta. the absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. as these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. this is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile. the use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (ek 2008-23). this method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, feppi and nafeedta given at fortification level with a meal.


Eligibility criteria:
inclusion criteria: * serum ferritin \ 100 g/ l * women * \< 65 kg body weight * healthy exclusion criteria: * pregnant or lactating * taking iron supplements

Keywords: iron absorption stable isotopes nafeedta non-transferrin-bound iron (ntbi) hepcidin
alemtuzumab and rituximab in aplastic anemia

Conditions: Aplastic Anemia

Summary: the purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.


Eligibility criteria:
inclusion criteria: * patients with aplastic anemia diagnosis exclusion criteria: * patients with prior treatment with monoclonal antibodies and/or antithymocyte globulin. * patients with a diagnosis or history of hiv/aids, hepatitis b, hepatitis c, cytomegalovirus. * patients who do not agree to sign a letter of informed consent.

Keywords: alemtuzumab rituximab aplastic anemia cyclosporine
a safety and efficacy study of liris® in females with interstitial cystitis with hunner's lesions

Conditions: Cystitis, Interstitial; Ulcer

Summary: this is a safety and efficacy study of liris® in females with interstitial cystitis with hunner's lesions.


Eligibility criteria:
inclusion criteria: * diagnosis of interstitial cystitis with hunner's lesions/ulcers exclusion criteria: * previous treatment with liris® * interstitial cystitis/bladder pain syndrome, without hunner's lesions/ulcers
effectiveness of peer support on quality of life in recently diagnosed breast cancer patients

Conditions: Breast Cancer

Summary: this study examines effectiveness of peer support of breast cancer patients. half of the participants received peer support via telephone in addition to usual care and another half are give the usual care only.

seriously sick people need social support to maintain their quality of life. social support may be given by peers, who have experienced the same. in this study voluntary participants with recently diagnosed breast cancer were randomly allocated to intervention (n=130) or control (n=130) group. the intervention group received, in addition to usual care, peer support via telephone 1-5 times according to their own preference. the control group received usual care only. peer support was given by volunteered breast cancer survivors who were educated for giving peer support.

Eligibility criteria:
inclusion criteria: * recently diagnosed primary breast cancer * no other serious illnesses * ability to communicate in finnish or swedish (official languages in finland) * ability to fill in the questionnaires exclusion criteria: * some other serious illnesses * inability to communicate in finnish or swedish (official languages in finland) * inability to fill in the questionnaires

Keywords: peer group quality of life